Status:
COMPLETED
Adaptive Therapy for Post-Second-Line Advanced Breast Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
HER2-negative Metastatic Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of post-second-line metastatic breast cancer.
Detailed Description
This is a phase II, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of adaptive therapy in the treatment of post-second-line advanced breast c...
Eligibility Criteria
Inclusion
- Understands and voluntarily signs the informed consent form.
- Minimum life expectancy 16 weeks.
- Histologically or cytologically confirmed advanced invasive breast cancer.
- Histological type: human epidermal growth factor receptor 2 (HER2) negative.
- Prior failure of at least first-line treatment for metastatic disease.
- At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
- Premenopausal women must use medically acceptable contraception during the study.
- Compliance with the study protocol.
Exclusion
- Pregnant or breast feeding.
- Uncontrolled medical problems.
- Evidence of active acute or chronic infection.
- Hepatic, renal, cardiac, or bone marrow dysfunction.
- Concurrent malignancy or history of other malignancy within the last five years.
- Patients were unable or unwilling to comply with program requirements.
- Concurrent use of any other anti-cancer therapy.
Key Trial Info
Start Date :
August 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06533722
Start Date
August 4 2024
End Date
May 28 2025
Last Update
June 10 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060